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| Name | Class |
|---|---|
| Sage Products, Inc. | INDUSTRY |
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Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of risk factors is thus important in the development of strategies to prevent these potentially devastating infections. This study proposes a randomized, controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op surgical site infections in spine patients.
Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect (decrease rates) of SSI compared to patients who receive routine standard of care (soap and water pre-op, day of surgery and daily post-operative).
Pre-operatively patients scheduled for neurosurgical spine cases will be evaluated and approached for interest, if consenting process completed, patients will be randomized to one of 2 arms in 1:1 through a block randomization table.
Those enrolled into the study arm will receive the CHG cloths and instructions for use from research personal. Those randomized to the control arm will receive standard of care skin cleansing by nursing staff.
All subjects who have signed consent will have a skin swab culture taken the day of screening and prior to cleansing with Chlorhexidine gluconate wipes close to the intended incision line. The investigators will also obtain skin swab cultures at site of incision preoperatively on the day of surgery, post-op day 4 or time of discharge and at the 30 day follow up.
Both groups will be evaluated daily by study personnel for the development of SSI until post-op day 4 or hospital discharge whichever one comes first. After dressing removal, a daily high definition picture will be taken of the incision line to further document signs of SSI development (pictures will not have any patient identifiable information). Additional evaluations will take place at the 30 day (+/- 7 days) post-op visit. Blinded evaluators utilizing the CDC guideline will grade the incision line for presence of SSI. Measured change in skin flora will be performed by comparing skin swab cultures of intervention group versus standard of care group and individual changes pre and post operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Standard of care pre-operative cleansing with soap and water the night before and morning of surgery | |
| Intervention Arm | Experimental | 2% chlorhexidine gluconate cloths the night before and morning of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% chlorhexidine gluconate cloths | Drug | Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Surgical Site Infection Development at 30 Days Post-operative | Evaluation daily using the CDC guidelines, daily measurements and deidentified photos | post op day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op | Day of Surgery, Day of Discharge, 30 days post-op |
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Inclusion Criteria:
Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8547767 | Background | Abbey DM, Turner DM, Warson JS, Wirt TC, Scalley RD. Treatment of postoperative wound infections following spinal fusion with instrumentation. J Spinal Disord. 1995 Aug;8(4):278-83. doi: 10.1097/00002517-199508040-00003. | |
| Background | Balderston RA, Blumberg K (1991) Infection in spine surgery. In: Balderston RA, An HS (eds) Complications in spinal surgery. WB Saunders, Philadelphia, pp 157-168 | ||
| 8893444 |
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One participant signed consent, was randomized to the chlorhexidine arm, but their surgery was cancelled, so they did not start the study. There is no data for this subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Pre-operative Cleansing | Standard of care pre-operative cleansing with soap and water the night before and morning of surgery |
| FG001 | 2% Chlorhexidine Gluconate | 2% chlorhexidine gluconate cloths the night before and morning of surgery 2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Pre-operative Cleansing | Standard of care pre-operative cleansing with soap and water the night before and morning of surgery |
| BG001 | 2% Chlorhexidine Gluconate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Surgical Site Infection Development at 30 Days Post-operative | Evaluation daily using the CDC guidelines, daily measurements and deidentified photos | Posted | Count of Participants | Participants | post op day 30 |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care Pre-operative Cleansing | Standard of care pre-operative cleansing with soap and water the night before and morning of surgery |
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larger sample size needed to examine the relationship between normal skin cultures in the Chlorhexidine arm vs control and development of surgical site infections by day 30.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Card | Vanderbilt University Medical Center | 615-875-4611 | elizabeth.b.card@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2018 | Jan 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Background |
| Glassman SD, Dimar JR, Puno RM, Johnson JR. Salvage of instrumental lumbar fusions complicated by surgical wound infection. Spine (Phila Pa 1976). 1996 Sep 15;21(18):2163-9. doi: 10.1097/00007632-199609150-00021. |
| 5012590 | Background | Keller RB, Pappas AM. Infection after spinal fusion using internal fixation instrumentation. Orthop Clin North Am. 1972 Mar;3(1):99-111. No abstract available. |
| 4722945 | Background | Kostuik JP, Israel J, Hall JE. Scoliosis surgery in adults. Clin Orthop Relat Res. 1973 Jun;(93):225-34. doi: 10.1097/00003086-197306000-00022. No abstract available. |
| 4584242 | Background | Lonstein J, Winter R, Moe J, Gaines D. Wound infection with Harrington instrumentation and spine fusion for scoliosis. Clin Orthop Relat Res. 1973 Oct;(96):222-33. No abstract available. |
| 9507627 | Background | Roberts FJ, Walsh A, Wing P, Dvorak M, Schweigel J. The influence of surveillance methods on surgical wound infection rates in a tertiary care spinal surgery service. Spine (Phila Pa 1976). 1998 Feb 1;23(3):366-70. doi: 10.1097/00007632-199802010-00016. |
| 2053001 | Background | West JL 3rd, Ogilvie JW, Bradford DS. Complications of the variable screw plate pedicle screw fixation. Spine (Phila Pa 1976). 1991 May;16(5):576-9. doi: 10.1097/00007632-199105000-00016. |
| 12650399 | Background | Olsen MA, Mayfield J, Lauryssen C, Polish LB, Jones M, Vest J, Fraser VJ. Risk factors for surgical site infection in spinal surgery. J Neurosurg. 2003 Mar;98(2 Suppl):149-55. |
| 8539047 | Background | Calderone RR, Garland DE, Capen DA, Oster H. Cost of medical care for postoperative spinal infections. Orthop Clin North Am. 1996 Jan;27(1):171-82. |
| 8059266 | Background | Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003. |
| 17436915 | Background | Patel N, Bagan B, Vadera S, Maltenfort MG, Deutsch H, Vaccaro AR, Harrop J, Sharan A, Ratliff JK. Obesity and spine surgery: relation to perioperative complications. J Neurosurg Spine. 2007 Apr;6(4):291-7. doi: 10.3171/spi.2007.6.4.1. |
| 18303461 | Background | Rihn JA, Lee JY, Ward WT. Infection after the surgical treatment of adolescent idiopathic scoliosis: evaluation of the diagnosis, treatment, and impact on clinical outcomes. Spine (Phila Pa 1976). 2008 Feb 1;33(3):289-94. doi: 10.1097/BRS.0b013e318162016e. |
| 20066445 | Background | Pull ter Gunne AF, van Laarhoven CJ, Cohen DB. Incidence of surgical site infection following adult spinal deformity surgery: an analysis of patient risk. Eur Spine J. 2010 Jun;19(6):982-8. doi: 10.1007/s00586-009-1269-1. Epub 2010 Jan 12. |
| 19478664 | Background | Pull ter Gunne AF, Cohen DB. Incidence, prevalence, and analysis of risk factors for surgical site infection following adult spinal surgery. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1422-8. doi: 10.1097/BRS.0b013e3181a03013. |
| 19494763 | Background | Eiselt D. Presurgical skin preparation with a novel 2% chlorhexidine gluconate cloth reduces rates of surgical site infection in orthopaedic surgical patients. Orthop Nurs. 2009 May-Jun;28(3):141-5. doi: 10.1097/NOR.0b013e3181a469db. |
| 22889522 | Background | Karki S, Cheng AC. Impact of non-rinse skin cleansing with chlorhexidine gluconate on prevention of healthcare-associated infections and colonization with multi-resistant organisms: a systematic review. J Hosp Infect. 2012 Oct;82(2):71-84. doi: 10.1016/j.jhin.2012.07.005. Epub 2012 Aug 11. |
| 23388005 | Background | Climo MW, Yokoe DS, Warren DK, Perl TM, Bolon M, Herwaldt LA, Weinstein RA, Sepkowitz KA, Jernigan JA, Sanogo K, Wong ES. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013 Feb 7;368(6):533-42. doi: 10.1056/NEJMoa1113849. |
| 23363666 | Background | Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28. |
2% chlorhexidine gluconate cloths the night before and morning of surgery
2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op | Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op | Posted | Count of Participants | Participants | Day of Surgery, Day of Discharge, 30 days post-op |
|
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | 2% Chlorhexidine Gluconate | 2% chlorhexidine gluconate cloths the night before and morning of surgery 2% chlorhexidine gluconate cloths: Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths | 0 | 75 | 0 | 75 | 0 | 75 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 30 days post-op |
|